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Evaluation of a Mobile Phone App for Veterans With PTSD

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ClinicalTrials.gov Identifier: NCT03199742
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Jason Owen, VA Palo Alto Health Care System

Brief Summary:
The purpose of this study is to evaluate a mobile phone app designed to help Veterans with PTSD. Participants in this study will be randomized to receive one of 2 possible mobile phone apps. The term "randomized" means that which app a participant receives will not be based on any characteristic or behavior of the participant, but will be determined solely by chance like a flip of a coin.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Veterans Behavioral: Personalized App Coaching Behavioral: Active Comparator Not Applicable

Detailed Description:
Participants will receive access to the mobile app "PTSD Coach". Participants will be randomized (by computerized coin flip) to one of two versions of the mobile app. All versions of the app will provide comprehensive information and tools for managing trauma symptoms, but one version of the app will provide personalized, confidential coaching messages delivered by either a Veteran peer or clinical psychologist. Participants will be asked to complete an online survey before using the mobile phone application and again 8 weeks later. Participants will be provided with the option to complete a telephone interview after 8 weeks of using the mobile phone application. To be eligible, participants must be a U.S. military Veteran, age 18 or older, have received a previous diagnosis of PTSD, and own an iPhone or iPad device.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomized to receive one of 2 forms of the mobile phone application being tested in this study: with and without personalized coaching. Among those who receive coaching, participants will receive either peer-based coaching messages, clinician-based coaching messages, or automated messages.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of a Mobile Phone App for Veterans With PTSD
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Active Comparator: PTSD Coach with no Coaching
Participants will receive the PTSD coach mobile app.
Behavioral: Active Comparator
Mobile phone application providing extensive information about PTSD and treatment, tools for managing PTSD symptoms, self-monitoring using the PTSD Checklist, and resources for obtaining support.

Experimental: PTSD Coach with Peer Coaching
Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a Veteran peer.
Behavioral: Personalized App Coaching
All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study. Participants will be provided with feedback about recent progress & use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.

Experimental: PTSD Coach with Clinician coaching
Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a clinical psychologist.
Behavioral: Personalized App Coaching
All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study. Participants will be provided with feedback about recent progress & use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.

Experimental: PTSD Coach with Automated Coaching
Participants will receive the PTSD Coach + mobile app which will provide automated, personalized coaching for 8 weeks.
Behavioral: Personalized App Coaching
All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study. Participants will be provided with feedback about recent progress & use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.




Primary Outcome Measures :
  1. PTSD Checklist 5 [ Time Frame: 8 weeks ]
    Measures symptoms of post-traumatic stress disorder

  2. Functional Well-Being [ Time Frame: 8 weeks ]
    Measures functional well-being of Veterans across a number of domains, including self-care, romantic relationships, work, family functioning, and parenting. Subscale scores will be aggregated to create a summary score for this measure.

  3. Engagement with the Application [ Time Frame: 8 weeks ]
    Objectively-measured engagement with the intervention (# sessions)


Secondary Outcome Measures :
  1. Self-Efficacy for Coping [ Time Frame: 8 weeks ]
    Self-efficacy for managing symptoms of PTSD using an author-constructed outcome measure.

  2. Perceived Helpfulness of Intervention [ Time Frame: 8 weeks ]
    How helpful the intervention was for providing information and tools for managing PTSD.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • U.S. military Veteran
  • age 18 or older
  • previously diagnosed with PTSD
  • own an iPhone or iPad device

Exclusion Criteria:

  • no previous history of PTSD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199742


Contacts
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Contact: Jason Owen, PhD 650-493-5000 ext 23478 jason.owen@va.gov

Locations
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United States, California
VA Palo Alto Health Care System Menlo Park Division Recruiting
Menlo Park, California, United States, 94025
Contact: Jason Owen, PhD    650-493-5000 ext 23478    jason.owen@va.gov   
Sponsors and Collaborators
VA Palo Alto Health Care System

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Responsible Party: Jason Owen, Clinical Psychologist, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT03199742     History of Changes
Other Study ID Numbers: IRB-31533
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders